NuVasive Brigade Lateral System

K181386 · Nu Vasive, Incorporated · OVD · Aug 24, 2018 · Orthopedic

Device Facts

• Record ID: K181386
• Device Name: NuVasive Brigade Lateral System
• Applicant: Nu Vasive, Incorporated
• Product Code: OVD · Orthopedic
• Decision Date: Aug 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Brigade® Lateral System is interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade® Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Story

Intervertebral body fusion device; used in lumbar spine (L2-S1) for stabilization and fusion. Composed of PEEK interbody implant with titanium alloy markers and two titanium alloy bone screws. Requires use with supplemental posterior pedicle screw and rod fixation. Implanted by surgeons during spinal fusion procedures following discectomy. Provides structural support to disc space while bone graft facilitates fusion. Benefits patients by addressing discogenic back pain and spinal instability.

Clinical Evidence

No clinical or non-clinical bench testing studies were conducted. Evidence of substantial equivalence provided via Finite Elemental Analysis (FEA) and engineering rationale.

Technological Characteristics

Interbody implant made of PEEK-OPTIMAL LT1 (ASTM F2026) with titanium alloy (Ti-6A-4V ELI, ASTM F136/ISO 5832-3 or Ti-6A-4V, ASTM F1472) markers and screws. Mechanical interbody fusion device; no software or energy source.

Indications for Use

Indicated for spinal fusion in skeletally mature patients with symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two levels (L2-S1) or multilevel degenerative scoliosis, following at least six months of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• NuVasive Lumbar Interbody Implants (K161230)
• NuVasive Brigade Hyperlordotic System (K123045)
• CoRoent XLR Standalone System (K100043)

Submission Summary (Full Text)

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August 24, 2018

NuVasive, Incorporated Jessica Silverman Regulatory Affairs Specialist 7475 Lusk Blvd. San Diego, California 92121

Re: K181386

Trade/Device Name: NuVasive® Brigade® Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 31, 2018 Received: August 1, 2018

Dear Ms. Silverman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Melissa Hall -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

### K181386

Device Name NuVasive® Brigade® Lateral System

## Indications for Use (Describe)

The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade® Lateral System is interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade® Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> <div style="text-align:center;"><b>X</b></div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> <div style="text-align:center;"><b>X</b></div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| <span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> <div style="text-align:center;"><b>X</b></div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray. The logo is simple and modern, and the colors are muted and professional.

# 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### A. Submitted by:

Ms. Jessica Silverman Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 [phone]

Date Prepared: May 24, 2018

#### B. Device Name

| Trade or Proprietary Name: | NuVasive® Brigade® Lateral System |
|----------------------------|-----------------------------------|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVD |

#### C. Predicate Devices

The subject NuVasive Brigade Lateral System is substantially equivalent to the following devices:

Primary Predicate

- K161230 NuVasive Lumbar Interbody Implants ●
# Additional Predicates

- K123045 NuVasive Brigade Hyperlordotic System ●
- K100043 CoRoent XLR Standalone System 0

#### Device Description D.

The NuVasive® Brigade® Lateral System is an interfixated interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Lateral System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Lateral System intervertebral fusion device is composed of a PEEK interbody implant containing radiographic titanium alloy markers, and two (2) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMAL LT1) conforming to ASTM F2026 and titanium alloy (Ti-6A-4V ELI) conforming to ASTM F136 and ISO 5832-3 or (Ti-6A-4V) conforming to ASTM F1472. The purpose of this Premarket Notification in to implement design changes to the Brigade System previously cleared in K161230 (NuVasive® Lumbar Interbody Implant).

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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape in purple and gray, followed by the company name "NUVASIVE" in gray sans-serif font. The logo is simple and modern.

#### Indications for Use E.

The Brigade® Lateral System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade® Lateral System must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade® Lateral System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade® Lateral System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

#### F. Technological Characteristics

As was established in this submission, the subject Brigade® Lateral System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

#### G. Performance Data

Finite Elemental Analysis (FEA) and engineering rationale were provided as evidence that the modified design of the Brigade® Lateral System construct did not create a new worst case for performance testing. The results of testing and Finite Elemental Analysis demonstrate that the subject Brigade Lateral System is substantially equivalent to predicate devices. No non-clinical or clinical studies were conducted.

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Brigade® Lateral System has been shown to be substantially equivalent to legally marketed predicate devices.